Regulatory Review

Scientific Research and Regulatory Review of the Pesticide Label

Each pesticide must receive an EPA registration before it can be sold, distributed, or used in the United States. EPA’s Office of Pesticide Programs grants registration of a product only at the conclusion of a thorough evaluation process wherein toxicological, environmental, and product use information is examined. The EPA’s review of the data, and the issuance of a registration, complies with the agency’s mandate by the Federal Insecticide, Fungicide, and Rodenticide Act that the potential benefits of use outweigh any potential risks: that use, according to label directions, will not cause unreasonable adverse effects on humans, wildlife, or the environment.

A pesticide’s label is its primary communication to users. It reflects the numerous scientific studies and regulatory reviews generated by the registration process. The law requires pesticide users to read and follow label specifications. Through specific and general language, the label addresses potential and actual risks to wildlife (e.g., a label might state that drift and runoff from treated areas may be hazardous to aquatic organisms in neighboring areas).

Environmental Hazards Statement

The Environmental Hazards Statement forewarns the user of potential adverse effects on wildlife and/or the environment, which might result from the use of the product. This section of the pesticide label also identifies precautions to reduce or prevent exposure of wildlife and contamination of the environment. Much of the label language is determined by the reaction of the indicator species during laboratory toxicity testing, or as a result of actual cases of wildlife poisoning attributed to the pesticide. For example:

If the toxicological data indicates… Then the label must give the following instructions:
…Mammalian acute oral LD50 of 100 ppm or less This pesticide is toxic to wildlife.
…Fish acute LC50 of 1 ppm or less This pesticide is toxic to fish.
…Avian acute oral LD50 of 100 ppm or less This pesticide is toxic to wildlife
…Avian dietary LC50 of 500 ppm or less This pesticide is toxic to wildlife.
…Bee acute toxicity of 2 micrograms or less This pesticide is highly toxic to bees
…Field studies or investigations indicate that the use of the pesticide may result in fatality to birds, fish, or mammals. This pesticide is extremely toxic to wildlife or fish.

The following advisory statement must appear in the environmental hazard statement if the product is intended for outdoor use other than aquatic applications:

For terrestrial uses, do not apply directly to water, or to areas where surface water is present, or to intertidal areas below the mean high water mark. Do not contaminate water by the cleaning of equipment or disposal of wastes.

Where a hazard to a nontarget organism (excluding humans and domestic animals) exists, statements describing the nature of the hazard and the appropriate precautions to avoid potential accident, injury, or damage are required. These hazard statements are prescribed according to toxicological data (LD50 or LC50values) and field testing.

Examples

  • This pesticide is extremely toxic to fish and wildlife. Birds and wild mammals utilizing treated areas may be killed. Do not apply directly to water or to areas where surface water is present.
  • This product is highly toxic to bees exposed to direct treatment, or residues on crops or blooming weeds. Do not apply this product, or allow it to drift to blooming crops or weeds, if bees are visiting the areas to be treated.
  • Information designed to protect valuable resources and potential habitats may be indicated in the environmental hazards statement of the label by the listing of these advisories.

Examples

  • Pesticide X is a chemical which can travel (seep or leach) through soil and contaminate groundwater. Users are advised not to apply pesticide X where the water table (groundwater) is close to the surface, and where the soils are very permeable.
  • Do not apply when weather conditions favor drift from target areas.
  • This product may not be mixed or loaded within 50 feet of intermittent streams and rivers, or natural or impounded lakes and reservoirs.

Manufacturers Must Report Adverse Effects on Wildlife

Pesticide registration does not end the oversight process by EPA, or the responsibility of the manufacturer. Employees of manufacturers are required, under penalty of fine and/or imprisonment, to report any adverse pesticidal effects not previously submitted to EPA. Manufacturers may become cognizant of new information as a result of continued laboratory testing, or learn of incidents where field use of a product harmed wildlife or contaminated the environment. EPA, in cooperation with the pesticide manufacturer, may review labels as new information becomes available to ensure that the language is specific enough to protect wildlife. In addition, EPA may undertake a special review to determine whether their prior registration decisions continue to provide adequate environmental protection.

The EPA Special Review Process for Wildlife

The special review process (40 CFR Part 154.7) allows EPA legal recourse to reconsider all data, wildlife incidents, and regulatory decisions relevant to a prior registration of a pesticide. Four of the six criteria listed for special review specifically mention nontarget effects, effects on endangered species, habitat destruction, and the environment. Wildlife considerations, therefore, are important to decisions on the continued registration of pesticides.

A special review can be initiated anytime there is evidence that the use of a pesticide will cause unreasonable adverse effects on wildlife. Typically, a special review goes beyond the comparison of estimated environmental concentration to toxicity values, and includes evaluations of field studies or field incidents. Following a comprehensive reevaluation of the pesticide, EPA may 1) take no action, 2) alter the pesticide label language to further minimize risk, 3) classify the pesticide for restricted use, 4) eliminate specific uses, or 5) cancel or suspend the registration.

Authored by Fred Whitford, et al.

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The above information is the property of Purdue University, reprinted from Pesticides and Wildlife, PP-30. All information on authors and disclaimers relative to the use of this information can be found at that address.

Topics Included in this Module